FDA product code FBM: Cannula And Trocar, Suprapubic, Non-Disposable
FBM is the FDA product code for cannula and trocar, suprapubic, non-disposable. It is a Class I device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under FBM, from 3 different applicants. The average 510(k) review took 77 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Cannula And Trocar, Suprapubic, Non-Disposable |
| Device class | Class I |
| Regulation | 21 CFR 876.5090 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FBM clearance
Top FBM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solos Endoscopy, Inc. | 6 | 1990-04-18 |
| Core Dynamics, Inc. | 2 | 1994-01-11 |
| Snowden-Pencer | 1 | 1996-03-12 |
Most recent FBM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960400 | Snowden-Pencer | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | 1996-03-12 | 43 |
| K932021 | Core Dynamics, Inc. | ENTREE CANNULA FASCIA ANCHORS | 1994-01-11 | 263 |
| K911813 | Core Dynamics, Inc. | ENTREE CANNULA | 1991-07-19 | 87 |
| K900963 | Solos Endoscopy, Inc. | GS-4350 TROCAR ONLY, 5.5MM | 1990-04-18 | 50 |
| K900964 | Solos Endoscopy, Inc. | CANNULA AND TROCAR, 11MM | 1990-04-18 | 50 |
Recalls for FBM devices
openFDA lists no recalls for product code FBM.
Frequently asked questions
What is FDA product code FBM?
FBM is the FDA product code for cannula and trocar, suprapubic, non-disposable. It is a Class I device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel.
What device class is FBM?
Class I, regulation 21 CFR 876.5090. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FBM?
Across 9 cleared submissions the average was 77 days from receipt to decision (median 50).
Which companies have the most FBM clearances?
Solos Endoscopy, Inc. (6); Core Dynamics, Inc. (2); Snowden-Pencer (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FBM
- Run a recall and safety report across every FBM manufacturer
- Watch product code FBM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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